Electro-Acupuncture Treatment in Patients With Osteoarthritis Of The Knee (EATOAK)

Hospital Son Llatzer

Status: Completed

Conditions: Osteoarthritis, Knee

Treatments: Device: Electroacupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT02299713

ACU-001

Details and patient eligibility

About

The purpose of this study is to assess the efficacy of electroacupuncture (EA) on pain control, perception of pain, plasma cortisol and beta-endorphins levels, patient-perceived quality of life and use of pain medications, in people with chronic knee pain.

Full description

Previous randomised trials and meta-analyses have shown certain efficacy of acupuncture in some chronic painful conditions, in spite of methodological weaknesses. The hypothalamic-pituitary-adrenal (HPA) axis and the endogenous opioid (EO) system are the mechanisms appear to explain how acupuncture works in part. These systems have been shown to be important mediators of stress, pain and other stimuli. The Osteoarthritis Research International suggest that osteoarthritis (OA) treatment should be multidisciplinary and recommended acupuncture as one of 12 possible non-pharmacological modalities for treating OA.

This study is a randomized, double-blind, placebo-controlled trial, parallel design. 128 out-patients over 50 years with OA of the knee will be recruited from Mallorca, Spain. Participants will be randomly allocated into two groups: placebo/sham acupuncture, non insertion technique, and EA. Acupuncture treatments will be used the Traditional Chinese Medicine (TCM) style. The patients will be evaluated after a period of one month (2 sessions weekly), three months (1session monthly), six months (1 session every 45 days) and again one year later (1 session every 2 months), at the end of the study.

Enrollment: 160 patients

Sex: All

Ages: 50 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients of either sex with primary osteoarthritis of one or both knees fulfilling diagnostic criteria for osteoarthritis knee laid down by American College of Rheumatology.
• Patients also had to have a Kellgren-Lawrence (radiologic criterion) score of at least 2 and chronic pain in the knee joint for more than 3 months.

Exclusion criteria

• The patients with secondary osteoarthritis of knees
• Associated systemic arthropathies, e.g. rheumatoid arthritis and gout
• Patients on steroids
• Disease modifying drugs, e.g. methotrexate and azathioprine
• Patients with recent trauma in the area of acupuncture
• History of intra articular injection of steroid within last two months
• Patients missing two or more sessions of electro-acupuncture consecutively were excluded from the study

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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160 participants in 2 patient groups

placebo/sham acupuncture

Sham Comparator group

Description:

There are different types of controls used in acupuncture trials. We used the control described as sham and by some as minimal acupuncture. This group had the same schedule as the electro-acupuncture group. Sham acupuncture was administered, with the same duration and frequency and by the same specialist who performed the non-sham acupuncture. Retractable needles were placed into small adhesive cylinders, so that the needles were supported but did not perforate the skin. The acupuncturist placed the needles at the same points as the non-sham group and used the same pairs of electrodes to simulate the electrical connection.

Treatment:

Device: Electroacupuncture

Electroacupuncture

Active Comparator group

Description:

The electro-acupuncture device was a biphasic pulse generator. It was used with maximum tolerable intensity of current and a frequency of 3 Hz. The points were selected according to the Traditional Chinese Medicine meridian theory to treat knee pain. The points selected were local points St 34, St 35, St 36,Liv 8, Sp 10. One distal point St 44.A total of six needles were inserted into each leg by the acupuncturist (the out come measures were not specifically targeted to whether the patient had one or both knees involved). All patients belonging to this group experienced a De Qi sensation, which is a tingling and numbness sensation upon needling of specific points.

Treatment:

Device: Electroacupuncture